GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic, “Construct and Manage the Technical File and Design Dossier” on June 19. David R. Dills, Regulatory and Compliance Consultant, will be the Speaker at this session. Description:
This webinar discusses differences in the regulatory requirements needed for Technical Files (TF) and Design Dossiers (DD). This webinar is for those with some prior knowledge and understanding of the CE and Medical Devices Directive.
Companies working in the global regulatory environment need to have a clear understanding of what kind of TF and DD have to go into medical devices that are sold in different markets. TF and DD are different from each other from one important perspective: While TF is usually associated with Class I, Class II, Class IIa and IIb devices; the DD marking is needed for Class III devices.
The rule is that the TF and DD are proportionate to the class of device. So, a Class I device requires a less complex CE marking TF and DD than Class II and Class III devices. Another factor that needs to be taken into consideration is that once placed in the market; EU competent authorities or Notified Bodies (NB) have the right to pick up any device for inspection randomly and retain it for review, irrespective of whether which class it belongs to.
These are some of the nuances of TF and DD marking this webinar will highlight. It will cover the following areas:
o Learn the differences between the Tech File and Dossier and why the construction phase is so important
o Compile the EU Technical File or Design Dossier and ensure Format and Content expectations are addressed appropriately
o Understand why Design Dossier is viewed as a subset of the Tech Documentation with emphasis on “design”
o Determine exactly which materials need to be assembled
o NB must examine the application for examination of the design dossier and, if the product conforms to the relevant provisions of the Directive, issue the application with an EC design-dossier certificate
o Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
o Determine applicable standards and address company-specific SOPs for constructing and managing your files
o European Norms and Standards and other documents supporting Technical Files and Design Dossiers
o Guidance on Design-Dossier Examination and Report Content
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When: June 19, 10:00 AM PDT | 01:00 PM EDT
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By whom:
David R. Dills, Independent Regulatory & Compliance Consultant, currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology.
He also serves on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and as Advisor for the ASQ's Section 1506. He is a former Chair and Co-Chair and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.
David has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
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For whom:
The webinar will benefit
o All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview; however, it is assumed that customers/attendees have some prior MDD and CE Mark background as applicable
o Regulatory Affairs/Regulatory Affairs Specialists
o Clinical Affairs
o Quality and Compliance
o Marketing & Sales
o Distributors
o Engineering/Technical Services
o Consultants
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Duration: 90 minutes
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To enroll for this webinar, contact
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